Nelson Laboratories will conduct two classes for medical device manufacturers at the 2014 MD&M West Conference at the Anaheim Convention Center on Feb. 12 beginning at 10 a.m. in room #208AB, covering the most up-to-date information on material selection, ISO 10993 biocompatibility and reprocessing of reusable devices.
Additional medtech classes will include industry updates and information on ethylene oxide and radiation sterilization validation, packaging test methods and processing validations for newly manufactured devices.
Thor Rollins, biocompatibility specialist at Nelson Laboratories, will present an overview of changes the FDA made in its draft document regarding the implementation of ISO 10993, and insights into making smarter decisions when choosing materials for medical devices early in the validation process.
"Medical device manufacturers can save a lot of time and cost if they make smarter material selections before design begins," says Rollins. "We'll show you how, and provide the latest updates on what the FDA is thinking regarding ISO 10993 before the changes become an official guidance document."
Emily Mitzel, laboratory manager at Nelson Laboratories, will discuss human factors in reprocessing reusable device validations. She will address three specific residuals and the exact amounts appropriate for cleaning that came out of the AAMI/FDA roundtable discussion on "How clean is clean?" and many more industry updates on cleaning and sterilization validations for reusable medical devices.
Nelson Laboratories' complete class schedule in room 208AB will include:
- 10 a.m.: Materials Selection and ISO 10993 Biocompatibility Update – Thor Rollins, biocompatibility specialist
- 11 a.m.: Ethylene Oxide Sterilization Validation Overview – Dan Floyd, laboratory manager
- 1 p.m.:Radiation Sterilization Validations Overview – Martell Winters, senior scientist
- 2 p.m.: Packaging Test Methods for Validation of Sterile Barrier Materials – Wendy Mach, packaging section leader
- 3 p.m.: Process Validations for Newly Manufactured Devices-Is your New Device Clean? – Alexa Tatarian, study director
- 4 p.m.: Managing Human Factors in Reprocessing of Reusable Devices-Validation Considerations – Emily Mitzel, laboratory manager
Nelson Laboratories will be available at booth 3228 for the duration of MD&M West Feb. 11-13, 2014.
Source: Nelson Laboratories